Pharmaceutical Pharmaceutical 1645 Questions Ask question Search Order By: ActiveClear Filter 0 Votes 1 Ans FDA plans to revise its September 1991 guide to inspection about pharmaceutical chemicals and why the need to revise? Does Q7A not replace the 1991 guide? 1.48K viewsDrugsPharmaceutical 0 Votes 1 Ans What does Q7A mean? 1.54K viewsDrugsPharmaceutical 0 Votes 1 Ans USP requires water used in the manufacture of parenterals to be water for injection, WFI. Does Q7A conflict with this? 1.50K viewsDrugsPharmaceutical 0 Votes 1 Ans Now that we have Quality System Inspections and Q7A, can you describe what you envision as a typical FDA inspection of an API plant? 1.61K viewsDrugsPharmaceutical 0 Votes 1 Ans The new ICH guideline is a major step forward in ensuring the quality of APIs. How does the FDA plan to ensure that they are applied and interpreted consistently by field investigators, and who, when, and how it will be applied to overseas suppliers? Additionally, it is really encouraging to see the support and participation of FDA in this important series of workshops. How does the Agency plan to carry through this commitment within its own organization, for example, training of field staff, key review personnel in the application of Q7A to API manufacturing? 1.56K viewsDrugsPharmaceutical 0 Votes 1 Ans Any background, history on why the accountability for lab records was not included in Q7A? For example, numbered pages in a lab bound notebook or sequential lab sheets that cannot be duplicated. 1.61K viewsDrugsPharmaceutical 0 Votes 1 Ans How long does FDA allow a laboratory to effect corrective actions after an inspection has been made? 1.35K viewsDrugsPharmaceutical 0 Votes 1 Ans Has FDA established guidelines for the frequency of calibration of equipment (balances) used in nonclinical laboratory studies? 1.25K viewsDrugsPharmaceutical 0 Votes 1 Ans What are the GLP requirements for labeling of reagents purchased directly from manufacturers? 1.56K viewsDrugsPharmaceutical 0 Votes 1 Ans Does FDA reject nonclinical laboratory studies that have not been conducted in full compliance with the GLPs? 1.60K viewsDrugsPharmaceutical 0 Votes 1 Ans Based on FDA changing of the meaning of “should”, does this mean that Q7A will be applied differently in the US than in the EU? 1.68K viewsDrugsPharmaceutical 0 Votes 1 Ans How do you define a “significant structural element” in an API starting material? 1.31K viewsDrugsPharmaceutical 0 Votes 1 Ans How close can you get to the API and still call it an API starting material? 1.27K viewsDrugsPharmaceutical 0 Votes 1 Ans How early should a company discuss with FDA the company strategy, rationale and what we consider to be an API starting material for filing? 1.56K viewsDrugsPharmaceutical 0 Votes 1 Ans If you identify an API starting material vendor, does that vendor need to be audited or qualified? 1.52K viewsDrugsPharmaceutical 0 Votes 1 Ans Are internal audit reports mentioned in Section 2.4 subject to FDA review during an inspection? 1.63K viewsDrugsPharmaceutical 0 Votes 1 Ans Concerning the distinction that you made between ICH versus VICH for APIs for veterinary products, which standards do the FDA inspectors use in the plants producing APIs for US vet products? Are there any differences seen during a PAI, and which standards should a plant follow? 1.62K viewsDrugsPharmaceutical 0 Votes 1 Ans You said that the WHO has now decided to compare the Q7A document with its 1992 API GMPs., I heard previously that the WHO was adopting Q7A with no mention of this evaluation. Is this just a standard procedural issue at WHO or do they have specific concerns, doubts, problems with Q7A? 1.48K viewsDrugsPharmaceutical 0 Votes 1 Ans Do the CGMP regulations permit the destruction of an internal quality assurance audit report once the corrective action has been completed? 1.48K viewsDrugsPharmaceutical 0 Votes 1 Ans What should a firm do if its drug products or components have been subjected to improper storage conditions such as those caused by a natural disaster? 1.59K viewsDrugsPharmaceutical « Previous 1 2 … 11 12 13 14 15 … 82 83 Next » Question and answer is powered by anspress.net
